AUSTRALIA’S 20-year-old National Medicines Policy (NMP) lags behind other developed nations as 21st century phenomena such as disruptive innovation, precision medicine and climate change have transformed the landscape, say experts.
Developed cooperatively by the government, the pharmaceutical industry, health care professionals and consumers in 1999, the NMP provided “overarching policy direction around four interlinked pillars: timely access to the medicines that Australians need and at an affordable cost; medicines meeting appropriate standards of quality, safety and efficacy; quality use of medicines; and maintaining a responsible and viable medicines industry”.
In an exclusive podcast with InSight+ Associate Professor Orin Chisholm, Program Director of Pharmaceutical Medicine at the University of New South Wales (UNSW), and Dr Brendan Shaw, Principal at Shawview Consulting and Adjunct Senior Lecturer at UNSW, said technological breakthroughs, changes in the Australian population and the way doctors treat their patients had rendered the NMP obsolete.
“The issue is that it’s almost 20 years old and it has not been reviewed since it was developed at the end of the 20th century,” said Dr Shaw.
The NMP’s development was a “collaborative exercise”, he said, between health experts, government officials, industry and patient groups, but many involved agencies had since changed, been defunded or superseded.
According to Pharma in Focus, Professor Andrew Wilson, chair of the Pharmaceutical Benefits Advisory Committee, would head up a review of the NMP, due to start later in 2019. A name change may be part of the review’s agenda.
“I wonder whether we should broaden it to beyond just medicines,” Associate Professor Chisholm told InSight+.
“The title of the policy now is not really fit for the future of medicine. We’re seeing a major increase in medicine and devices working together with digitally enhanced medicines, with a massive increase in cell and gene therapy products. We’re on the verge of these products, there’s a wave, onslaught of these products coming through the development process,” she said.
The risk of not bothering with a national framework such as the NMP was “policy drift”, said Dr Shaw.
“Things will start to be done without a framework, and the risk is there’ll be little incremental decisions as all these major changes are happening in health care, [with] no broad comprehensive strategic discussion about what that means for Australians and the Australian policy system.
“How do we future-proof health care to make it more adaptable to the inevitable social and economic and technological changes that are likely to happen?”
Associate Professor Chisholm said the model of health care in Australia had significantly changed since the turn of the century.
“There’s a move to coproduction of health care and more patient-centred health care,” she told InSight+.
“[We should take into account] those different emphases compared with when the policy was put in place, [to see] we need to make any adjustments to it going forward into the future.
“Back in 1999 when the policy came in, we had a lot of small molecule products,” she said.
“The big sellers were the statin products for cholesterol – big advances and products that affected large numbers of patients.
“Today, we’re seeing a lot more personalised medicine and rare diseases as the focus for medicines development. They are correspondingly more complex medicines to develop, a lot more biological-based medicine, monoclonal antibodies.
“They’re very complex to manufacture. The supply chain is much more complex than the tablets that were the major pillar of medicine’s development in the late 20th century. We’ve seen a lot of progress and more complexity in the process of developing new medicines.”
Associate Professor Chisholm and Dr Shaw have written a Perspective, published in the MJA, detailing the social and economic changes since 1999 that necessitate the review.
“How will disruptive innovation, digital and information technologies, precision medicine, the interaction of medicines with devices and diagnostics, changing consumer preferences in areas such as complementary medicines, an ageing population, climate change, immigration, the geopolitical and economic environment, and the emerging economies in the world affect Australia’s medicines policy environment going forward?” they wrote.
They suggested some issues that should be included in the review: pharmaceutical waste disposal and environmental protection; management and disposal of unsafe and unwanted medicines; antimicrobial resistance and antibiotics; information technology, data analysis, web-based systems; electronic media; patient responsibility and health literacy; health workforce planning and development; intellectual property; and globalisation, international cooperation and global health issues.
“Finally, there is a need for an awareness campaign for policy makers, politicians, the private sector, stakeholders and the community on what the NMP is and what it does.
“A review of the NMP is overdue and could not be timelier with its 20th anniversary fast approaching.”